Kornimate/medical-research-clean huggingface dataset:
phase ii safety and efficacy study to evaluate a glaucoma therapy in open-angle glaucoma or ocular hypertension patients

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: to determine the safety and iop-lowering ability of a test compound in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension; * logmar visual acuity not worse than 0.6. exclusion criteria: * clinically relevant ophthalmic or systemic conditions may be excluded.

Keywords: open-angle glaucoma ocular hypertension poag
safety and efficacy of taclonex ointment in adolescent patients (aged 12 to 17 years) with psoriasis vulgaris

Conditions: Psoriasis Vulgaris

Summary: the purpose of this study is to evaluate the safety and efficacy of 4 weeks of taclonex ointment in adolescent patients with psoriasis vulgaris.

taclonex ointment has marketing approval in many countries for the treatment of psoriasis vulgaris in adults. no studies have been conducted in patients less than 18 years of age. however, about 25% of affected individuals are diagnosed between 10 and 19 years of age, hence psoriasis is also prevalent in the adolescent age group (12-17 years). all patients will receive taclonex. to evaluate the safety of taclonex ointment, all adverse events will be recorded. in addition, any systemic absorption of the active components, betamethasone dipropionate and calcipotriene, will be evaluated by assessing adrenal function (using cortrosyn™ test) and calcium metabolism (by measuring serum calcium and the urinary calcium:creatinine ratio), respectively.

Eligibility criteria:
inclusion criteria: * aged 12 to 17 years, inclusive. * psoriasis vulgaris on the trunk and/or limbs which is: * amenable to topical treatment * of an extent of 5-30% of bsa * of at least a moderate severity * a serum cortisol concentration above 5 mcg/dl before acth-challenge and above 18 mcg/dl at 30 minutes after acth-challenge. * albumin-corrected serum calcium and urinary calcium:creatinine ratio within the reference range. exclusion criteria: * serious allergy, serious asthma, or serious allergic skin rash. * a history of sensitivity to any medication. * puva or grenz ray therapy, uvb therapy, systemic treatment with biological therapies, corticosteroids, or other therapies with an effect on psoriasis, topical treatment with corticosteroids or vitamin d analogues, treatment with enzymatic inductors, cytochrome p450 inhibitors, hypoglycemic sulfonamides, antidepressive medications, estrogen therapy, calcium supplements or vitamin d supplements. * guttate, erythrodermic, exfoliative or pustular psoriasis. * viral lesions of the skin, fungal or bacterial skin infections, ulcers or wounds. * severe renal insufficiency, severe hepatic disorders, disorders of calcium metabolism associated with hypercalcemia, any cardiac condition or endocrine disorder. * diabetes mellitus * cushing's disease or addison's disease.
novel energy metabolic signaling molecule with therapeutic potential

Conditions: Healthy Participants

Summary: altogether a 25-day study. first 4 days non-blinded with water before 0-control blood samples (day0). thereafter blinded for 21 days (3 weeks). study group was apparently healthy 50-60 -year-old males and females (n=27).

blinded 21-day period was divided into two sub-periods (7 days and 14 days) and it included 3 measurement days. all measurements were on the same day of each week to facilitate maximal comparability (day0, day7 and day21). additionally on day0 and day7 there were acute measurements 45 minutes after morning "non-acute" resting and fasting blood samples. (in a "non-acute" measurement last dose of panavital or placebo was taken 12 hours before the "non-acute" blood sample collected next morning .) first week started with day0 baseline measurements and immediately thereafter a strenuous vo2max test with 2 recovery days thereafter. after full recovery a 4-day blinded panavital regimen. last "non-acute" dose on day6 was taken 12 hours before day7 morning blood sample. at day7 an acute 45 min placebo comparison was conducted. thereafter a 14-day follow-up period with halved panavital dose or placebo. altogether 5 arterial blood samples were withdrawn. three fasting and resting "non-acute" samples were taken in the morning before any treatments at day0, day7 and day21. two acute samples were collected after the vo2max (day1) and after acute panavital or placebo doses (day7). additionally 5 fingertip blood samples for glucose (and lactate) were taken at the same time as arterial samples (day0 and day7) and one fingertip sample was taken immediately at the end of vo2max.

Eligibility criteria:
inclusion criteria: * healthy 50-60 year-old females and males exclusion criteria: * history of cardiovascular diseases, overweight (bmi \>32)
massage therapy on hamstrings in patients with nonspecific low back pain

Conditions: Low Back Pain

Summary: effectiveness of a technique of dynamic massage therapy in the hamstrings in patients with nonspecific low back pain.

the main objective of this study is to test the effectiveness of a technique of dynamic massage therapy in the hamstrings in patients with nonspecific low back pain. secondary objectives are assess whether the technique of dynamic massage therapy increases the extensibility of the hamstrings, assess whether the treatment of hamstrings decreases low back pain and determine whether the application of this technique decreases the disability associated with nonspecific low back pain.

Eligibility criteria:
inclusion criteria: * 18-65 years old. * low back pain with over three months of evolution. * practice sports regularly (at least three times a week). exclusion criteria: * fractures, tumors, congenital anomalies, rheumatic diseases, infectious or inflammatory processes. * pathology nerve root * presence of neurological deficit or neuromuscular diseases. * surgery * physiotherapy treatment for low back pain in the last 30 days. * drugs in previous 24h
erlotinib as neoadjuvant treatment in patients with stage ⅲa n2 nsclc with activating egfr mutation.

Conditions: Non Small Cell Lung Cancer

Summary: this is a single arm, one center, phaseⅱ study evaluating efficacy and safety of erlotinib as neoadjuvent treatment in patients with ebus confirmed stage ⅲa n2 nsclc with activating egfr mutation in exon 19 or 21.

screening phase: patients clinically diagnosed as stage ⅲa n2 lung caner by ct technique will be pathologically proven as nsclc with n2 by ebus. the pathology specimen will be detected egfr mutation by dna sequencing. the patients with egfr mutation in exon 19 or 21 will be enrolled in this study. neoadjuvant treatment phase: patient will receive erlotinib 150mg/day. treatment will be scheduled to continue for a total of 8 weeks or disease progression or unacceptable toxicities. surgery treatment phase: tumor response will be evaluated with ct scan after 8 weeks of induction treatment. the patients with responsive disease considered to be technique resectable will undergo resection. post-surgery phase: it is the discretion of the investigator whether the patient is a candidate for post-operative treatment which is considered to be in the best interest of the patients. it is recommended that patients with positive margins or residual tumor after surgery should receive radiation therapy. patients after surgery will receive long-term follow-up including chest ct scan every 3 months for up to 2 years.

Eligibility criteria:
inclusion criteria: written informed consent provided. males or females aged ≥18 years. able to comply with the required protocol and follow-up procedures, and able to receive oral medications. stage iiia n2 nsclc according to the pathological evidence of endobronchial ultrasound(ebus). the biopsy specimen shows egfr mutation in exon 19 or 21 by dna sequencing. measurable disease must be characterized according to recist criteria: measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20cm with conventional techniques (pe, ct, xr, mri) or as ≥ 10cm with spiral scan. ecog performance status 0-1. life expectancy ≥12 weeks. female subjects should not be pregnant or breast-feeding. exclusion criteria: the biopsy specimen shows egfr wildtype in exon 19 or 21 by dna sequencing. patients with prior exposure to agents directed at the her axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab). patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy). known hypersensitivity to tarceva or any of its recipients. evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the subject at high risk for treatment-related complications. sexually active males and females(of childbearing potential) unwilling to practice contraception during the study.

Keywords: neoadjuvant treatment
traditional clomiphene citrate administration vs. stair-step approach

Conditions: Ovulatory Dysfunction; Anovulation; Ovulation Induction

Summary: the purpose of this study is to compare the length of time to achieve ovulation and pregnancy with a traditional protocol administration of clomiphene citrate versus a stair step administration. our hypothesis is by using a stair-step approach in which a period is not induced between administrations of escalating doses of clomiphene citrate, the time to ovulation and pregnancy may be reduced.

the traditional administration of clomiphene citrate for ovulation induction involves taking clomiphene citrate for 5 days. if ovulation does not occur within 14 days, a progestin pill (such as provera) is prescribed for 10 days to induce a period (which normally occurs within 1 week of stopping the pill). then a higher dose of clomiphene citrate will be prescribed. the stair-step administration of clomiphene citrate for ovulation induction also involves taking clomiphene citrate for 5 days. in contrast, if ovulation does not occur within 7-9 days, a progestin pill (such as provera) would not be taken to induce a period. the dose of clomiphene will then be increased. therefore, this would do away with the 10 days of taking the progestin pill, and also do away with waiting for a period (usually 3 to 7 days) for a total of up to a 20 day difference between clomiphene citrate dosing cycles.

Eligibility criteria:
inclusion criteria: * ovulatory dysfunction as evidenced by mid-luteal progesterone less then 3ng/dl, non-biphasic basal body temperature charting, or menstrual history of cycles \> 35 days. * female patients 18 to 45 years old * six months or greater of unprotected intercourse without pregnancy. * normal tsh and prolactin serum levels * semen analysis of male partner with \> 15 million motile sperm on semen analysis. * note: must be willing to travel to the oklahoma city area for treatment. exclusion criteria: * failure to spontaneously menstruate or to menstruate following progestin administration * allergy or intolerance to the side effects of clomiphene citrate, hcg (human chorionic gonadotropins), or medroxyprogesterone acetate (provera). * known anatomical defect affecting the uterine cavity including submucosal fibroids or endometrial polyps. * know tubal hydrosalpinx or risk factors for tubal obstruction * known liver dysfunction * known or suspected androgen secreting tumor, cushings disease, or adrenal hyperplasia (congenital or adult onset) * ovarian cyst \> 20mm or endometrial lining \>6 mm on trans-vaginal baseline ultrasound. * stage iii or iv endometriosis * decreased ovarian reserve as evidenced by antral follicle count less than 6 by transvaginal ultrasound or a cycle-day-3 serum fsh of \> 10 uiu/ml. * positive hiv in either the female patient or her partner.

Keywords: anovulation ovulation induction
lerisetron compared with granisetron in preventing nausea and vomiting in men being treated with radiation therapy for stage i seminoma

Conditions: Nausea and Vomiting; Testicular Germ Cell Tumor

Summary: rationale: antiemetic drugs may help to reduce or prevent nausea and vomiting in patients treated with radiation therapy. it is not yet known whether lerisetron is more effective than granisetron in preventing nausea and vomiting. purpose: randomized phase iii trial to compare the effectiveness of lerisetron with that of granisetron in preventing nausea and vomiting in men who are being treated with radiation therapy for stage i seminoma.

objectives: i. compare the efficacy and safety of lerisetron versus granisetron hydrochloride in the prevention of radiotherapy induced nausea and vomiting in men with stage i testicular seminoma. outline: this is a randomized, double blind, parallel, multicenter study. patients are randomized to one of three treatment arms. arm i: patients receive oral lerisetron with an oral placebo once daily for 14 days. arm ii: patients receive oral lerisetron once daily for 14 days. arm iii: patients receive oral granisetron hydrochloride once daily for 14 days. at 1-2 hours following antiemetics, all patients undergo concurrent daily radiotherapy for at least 10 out of 14 days. patients are followed daily for 10 days. projected accrual: a total of 150 patients (50 per treatment arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: diagnosis of stage i seminoma no clinical evidence of brain metastases patient characteristics: age: 18 to 70 sex: male performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: no significant hepatic impairment renal: no significant renal impairment other: no known hypersensitivity to serotonin antagonists no prior anticipatory emesis no communication impairments (e.g., language problem, poor mental development, or impaired cerebral function) that would preclude study prior concurrent therapy: biologic therapy: not specified chemotherapy: not specified endocrine therapy: no concurrent corticosteroids except topical 1% hydrocortisone or equivalent radiotherapy: no prior radiotherapy surgery: not specified other: at least 48 hours since prior antiemetics no other concurrent antiemetics

Keywords: nausea and vomiting stage i malignant testicular germ cell tumor testicular seminoma
rct of the naturopathic anti-inflammatory diet

Conditions: Diabetes Mellitus, Type 2; Prediabetes

Summary: the purpose of this study is to determine if the naturopathic anti-inflammatory diet results in reduced inflammation and a better response by the immune system when compared to a standard diabetic diet based on the current american diabetes association guidelines.

this study will test the effects of two different diets on the immune system and inflammation in diabetes and pre-diabetes. these diets are the "anti-inflammatory diet" (ai diet) used by many naturopathic doctors and a standard diabetic diet based on the american diabetes association recommendations (ada diet). the ai diet excludes wheat, dairy products, eggs, red meat, caffeine, alcohol, peanuts and certain fruits and vegetables. the ada diet includes most foods but controls the amount of each of the food groups. naturopathic physicians often use healthful diets to treat diseases but many of these diets have not been compared to usual medical diet treatments. we will be looking at blood markers that show how the immune system responds to the different diets. we are expecting that the ai diet will result in less inflammation and a better response by the immune system than the ada diet. we will also be looking at levels of blood lipids and glucose to see any effects on these risk factors.

Eligibility criteria:
inclusion criteria: * bmi: 25-45 kg/m2 * age 18-75 yrs * diagnosed with type 2 diabetes or pre-diabetes * at risk for type 2 diabetes. must meet 2 of the following 3 criteria: bmi 30-45 kg/m2, age 50 or older, and/or family history of type 2 diabetes * fasting blood glucose of 100-200 mg/dl * provide informed consent exclusion criteria: * current major debilitating mental or physical illness that would interfere with participation (as determined by the participant's medical history) * taking diabetic medication other than sulfonylurea * taking gymnema silvestra (a naturopathic diabetes treatment) * taking medications that have anti-inflammatory affects (lipid lowering agents, nsaids, cox 2 inhibitors, aspirin, hrt, oral contraceptives, testosterone, seizure medications) * taking weight loss medications * severe renal, hepatic, or heart disease * triglycerides \>500 mg/dl * bulimia * pregnancy or lactation * current excessive use of alcohol * current/recent chronic use of recreational drugs * smoker * more than 4 hours/week of aerobic exercise * have gained or lost more than 15 pounds during previous 6 months * planning on moving out of the area in the next 4 months * is a participant in another medical research study * is following a weight loss diet * is unwilling to accept random assignment of the experimental diets * food preferences and/or allergies that will interfere with consumption of experimental diet

Keywords: diabetes pre-diabetes anti-inflammatory diet diet study inflammation diabetic diet
neoadjuvant chemotherapy of nimotuzumab plus nab-paclitaxel in squamous cell carcinoma of esophagus

Conditions: Squamous Cell Carcinoma of Esophagus

Summary: nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (egfr),has been shown to be effective and safe in some studies with head-neck cancers.nab-paclitaxel regimen in advanced nsclc has a better tumor response rate and safety than solvent-based paclitaxel.however,the safety and efficacy of nimotuzumab plus nab-paclitaxel regimen is uncertain in neoadjuvant therapy in esophageal cancer.the investigators then initiated a phase ii clinical trial with nimotuzumab plus nab-paclitaxel/cisplatin as the neoadjuvant chemotherapy in patients with locally advanced esophageal squamous cell carcinoma to observe the efficacy and safety of the combination.

in the past decade, clinical trials have evaluated the role of neoadjuvant chemotherapy, radiation, or both, for patients with surgically resectable esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. in eastern countries, preoperative chemotherapy followed by radical surgery became one of the treatment strategies for resectable, clinical stage ii or iii esophageal cancer. in an effort to improve the efficacy of systemic chemotherapy, we conducted a prospective study to evaluate the regimen of nimotuzumab plus nab-paclitaxel/cisplatin as perioperative therapy for patients with resectable esophageal squamous cell carcinoma.

Eligibility criteria:
inclusion criteria: * histologically confirmed squamous cell carcinoma of the thoracic esophagus, including the gastroesophageal junction (siewert type i) * locally advanced disease that is technically operable with curative intent (r0) * t3, n0 or t1-3, n+ or t4, nx * no t1-2, n0 * no inoperable t4 (unequivocal organ involvement) * no distant metastasis, including m1a lymph node status * lymph nodes suspicious of m1a status by ct scan, pet scan, or ultrasound must be verified by fine-needle aspiration cytology * no carcinoma of the cervical esophagus * obstructive tumors allowed exclusion criteria: * not suitable to surgery * cervical esophageal carcinoma(distance of incisor tooth\<19cm) * early esophageal carcinoma(stage i) * complete esophageal obstruction，esophageal perforation or hematemesis * other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ * pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives * uncontrolled seizures or psychiatric diseases, loss of control over their own behavior * history of serious allergic or castor oil allergy * patients who are not suitable to participate in the trial according to researchers

Keywords: neoadjuvant chemotherapy nimotuzumab nab-paclitaxel carcinoma of esophagus
efficacy of preoperative muscle training on postoperative orthopaedic surgery recovery

Conditions: Arthroplasty; Osteoarthritis

Summary: the purpose of this study is to assess the effectiveness of a preoperative muscle training program on hip or knee tja (total joint arthroplasty). it aims to improve hospital discharge readiness and functional capacity in both the short and long-term. one of the key factors affecting recovery after tja is how well the patient functions before their surgery. thus, interventions addressing preoperative function are expected to be beneficial.

although total hip or knee joint replacement is beneficial in treating severe hip or knee osteoarthritis, a significant number of patients take longer to recover in the hospital or have a non-optimal quality of life after the surgery. these patients often have difficulties in accomplishing basic essential everyday tasks such as walking and stair climbing, both shortly and long after surgery. it has been previously shown through research that difficulties to do basic tasks before surgery delays recovery and negatively affects long-term function. it has also been shown that these difficulties are associated with reduced strength in hip or knee muscles present before surgery, caused by lack of activity of patients. this study will determine if a hip or knee muscle strengthening exercise program accomplished before surgery can improve hospital recovery, capacity to accomplish basic activities, and quality of life two days, six weeks and six months after joint replacement surgery. if this exercise program is shown to be beneficial, it will be easily used by patients when waiting for their surgery.

Eligibility criteria:
inclusion criteria: * patients aged 18 and older undergoing unilateral total hip or knee arthroplasty due to osteoarthritis; * womac functional subscale less than 66.5/100. exclusion criteria: * patients under 18 years of age; * patients undergoing joint revision on the affected side; * patients under the same day discharge protocol; * patients undergoing bilateral arthroplasty; * patients suffering from other previously diagnosed lower-limb problems limiting their capacity to accomplish the exercise program; * patients having surgery in less than 16 weeks after verbal consent; * patients unable or unwilling to commit to required study follow-ups; * patients with no fixed address; * patients with a cognitive impairment that may preclude questionnaire completion; * pregnant or suspected pregnant women as dual-energy x-ray (dxa) used in this study may be harmful to a fetus.
an open-label, single-dose, two-treatment, randomized, cross-over study to investigate the effects of the slco2b1 c.1457c>t polymorphism and apple juice on the pharmacokinetics and pharmacodynamics of acebutolol in healthy korean and japanese volunteers

Conditions: Healthy

Summary: an open-label, single-dose, two-treatment, randomized, cross-over study to investigate the effects of the slco2b1 c.1457c\>t polymorphism and apple juice on the pharmacokinetics and pharmacodynamics of acebutolol in healthy korean and japanese volunteers


Eligibility criteria:
inclusion criteria: * subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an institutional review board (irb) - approved informed consent prior to performing any of the screening procedures exclusion criteria: * a subject with history of allergies including study drug (acebutolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies

Keywords: slco2b1 genotype effect of apple juice